In April, 2003, Gynecare Worldwide, a division of Ethicon, Inc., the product distributor, issued a voluntary withdrawal of Gynecare Intergel Adhesion Prevention Solution and advised that customers immediately stop using the product. Gynecare received reports of post-operative pain and repeat surgeries following the onset of pain, non-infectious foreign body reactions, and tissue adherence.
The product, manufactured by Lifecore Biomedical, Inc. and marketed by Johnson & Johnson's Gynecare unit, was used from 1998 to the recall date to help reduce post-operative internal scarring that led to intestinal obstruction and chronic pain. It has also been used "off-label" in laparoscopy and other surgical procedures such as hysterectomy.
Some history of Gynecare IntergelThe Food and Drug Administration (FDA) approved Intergel in November 2001 as an anti-adhesion surgical gel for gynecological surgeries, but the agency originally refused to approve the product, determining that the gel actually increased a woman's risk of infections. The manufacturer appealed the denial and the FDA reevaluated its decision: the appeal commission reversed the FDA's initial denial and approved the adhesive, but only as "reasonably safe." According to the FDA, 5.6% of those who received the gel developed an infection at the surgical site compared to only 2.9% of women who received more conventional treatment.
The manufacturer of Gynecare Intergel Adhesion Prevention Solution is currently assessing technical issues, surgical techniques and circumstances associated with these post-market events.
If you have experienced health problems because of Intergel, see your doctor. You may also want to contact a lawyer who can help protect your legal rights. Please keep in mind that there may be a statute of limitations - act now rather than later.
Articles about Gynecare IntergelGynecare Intergel: Why was it Approved?
Recent headlines announcing the reinstatement of still-worrisome drugs is an eerie reminder of what happened when Gynecare Intergel Adhesion Prevention Solution was initially considered by the U.S. Food and Drug Administration (FDA). Voluntarily pulled from the market by Johnson&Johnson (an Ethicon company) in 2003, Intergel has since been at the centre of numerous lawsuits.
Intergel Scandal: A "Dangerous Precedent" at FDA?
In the wake of the Gynecare Intergel recall, many critics are questioning why the Food and Drug Administration (FDA) ever approved Intergel for medical use. Could it be, as some suggest, that the FDA is playing politics to its drug-company funders?
Off-Label Use Sinks Gynecare Intergel
The Short, Unhappy History of Intergel
Gynecare: A Red Flag Ignored
Gynecare Intergel: More Lawsuits Pending?
Gynecare Intergel Linked To Pain, Tissue Adherence, and Internal Scarring